AutoPulse®Resuscitation System 100 (REF 8700-0740-11)Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00849111001090), received between Aug 22, 2018 and Aug 13, 2026 — classified as 36 malfunctions.

The most frequently reported specific device problem is “Visual Prompts will not Clear” (27 reports).

1 other recall cover devices cleared under the same FDA submission (K112998); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2026Visual Prompts will not Clear

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50241622 ↗
• MalfunctionFeb 10, 2026Visual Prompts will not Clear

  THE CUSTOMER WAS USING THE AUTOPULSE PLATFORM (SN (B)(6)) IN A CATH LAB DURING PCI (PERCUTANEOUS CORONARY INTERVENTION), WHILE THE PATIENT WAS IN CARDIAC ARREST. THE CUSTOMER REPORTED THE PATIENT BEING OBESE AND WEIGHING AROUND 110KG. THE FIRST 20 MINUTES PASSED WITHOUT ANY ISSUES. THE BATTERY WAS CHANGED AT THIS POINT, BUT USER ADVISORY 02 (COMPRESSION TRACKING ERROR) APPEARED ON THE SCREEN. LIFEBAND WAS SET LOOSE, EXTENDED, AND PLACED AGAIN ON THE PATIENT'S CHEST. HOWEVER, AFTER A SHORT PERIOD OF COMPRESSIONS, THE UA02 ADVISORY MESSAGE REAPPEARED. THE CREW READJUSTED THE LIFEBAND REPEATEDLY, BUT THIS DIDN'T RESOLVE THE ISSUE FOR LONG. AFTER A WHILE, THEY DECIDED TO STOP USING AUTOPULSE AND STARTED MANUAL COMPRESSIONS DURING THE PROCEDURE. THE PATIENT DID NOT SURVIVE. THE CUSTOMER HASN'T CLAIMED THAT THE PATIENT'S DEATH WAS RELATED TO THE ALLEGED DEVICE MALFUNCTION. AFTER THE PROCEDURE, THE CUSTOMER CHANGED THE LIFEBAND AND TESTED THE DEVICE, AND IT WORKED WITHOUT AN ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310329 ↗
• MalfunctionMar 3, 2025Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(6) ) DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) MESSAGE. THE CUSTOMER TRIED TO CLEAR THE (UA) 07 ERROR MESSAGE BY REPLACING THE LIFEBAND, BUT THE ERROR PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21511373 ↗
• MalfunctionOct 9, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM SN (B)(6), DISPLAYED A FAULT 16 (TIMEOUT MOVING TO TAKE-UP POSITION) MESSAGE UPON POWERING ON. THE CUSTOMER TRIED TO CLEAR THE FAULT CODE BY REMOVING AND RESETTING THE LIFEBAND, BUT THE FAULT CODE PERSISTED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409853 ↗
• MalfunctionSep 17, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (B)(6) DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240671 ↗
• MalfunctionFeb 13, 2024Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM SN (B)(6) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE UPON POWERING ON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18699772 ↗
• MalfunctionOct 18, 2023Failure to Power Up; Failure to Power Up

  A ZOLL TERRITORY MANAGER REPORTED THAT THE EVAL AUTOPULSE PLATFORM SN (B)(6) DOES NOT TURN ON ANYMORE. THE PLATFORM HAS BEEN TESTED WITH DIFFERENT AUTOPULSE LI-ION BATTERIES BUT THE OUTCOME WAS ALWAYS THE SAME. THERE IS NO VISIBLE DAMAGE TO THE POWER BUTTON. THE PLATFORM WAS BEING OPERATED BY ZOLL PERSONNEL AT THE TIME OF THE FAILURE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17959765 ↗
• MalfunctionFeb 20, 2023Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE INVESTIGATION ON 02/15/2023, THE AUTOPULSE PLATFORM (SN (B)(4) FAILED FUNCTIONAL TESTING AND DISPLAYED USER ADVISORY (UA) 17 (MOTOR ON FOR TOO LONG DURING ACTIVE OPERATION) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401906 ↗
• MalfunctionSep 11, 2022Use of Device Problem; Visual Prompts will not Clear; Noise, Audible; Use of Device Problem; Visual Prompts will not Clear; Noise, Audible

  DURING PREVENTIVE MAINTENANCE (PM) PERFORMED AT ZOLL, THE DRIVETRAIN MOTOR OF THE AUTOPULSE PLATFORM (S/N (B)(4)) RAN WITH NO POWER AND WAS UNUSUALLY LOUD. DURING FURTHER TESTING, THE PLATFORM STOPPED COMPRESSIONS AND DISPLAYED FAULT CODE 16 (TIMEOUT MOVING TO TAKE-UP POSITION). NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397846 ↗
• MalfunctionMay 2, 2022Use of Device Problem; Use of Device Problem

  DURING THE PATIENT USE, THE USER NOTICED A BURNT SMELL FROM THE AUTOPULSE PLATFORM (SN (B)(4) AND THE PLATFORM STOPPED COMPRESSIONS. THERE WERE NO ERROR MESSAGES DISPLAYED ON THE AUTOPULSE PLATFORM. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14261580 ↗
• MalfunctionFeb 15, 2022Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13538939 ↗
• MalfunctionDec 1, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING THE SHIFT CHECK, THE AUTOPULSE PLATFORM ((B)(4)) DISPLAYED USER ADVISORY (UA) 02 (COMPRESSION TRACKING ERROR) ERROR MESSAGE. IN ADDITION, ONE OF THE ENCLOSURES ON THE BOTTOM OF THE PLATFORM WAS NOTED BROKEN AND THE PLATFORM MAKES AN ABNORMAL SOUND WHEN THE LIFEBAND STARTS TO COMPRESS. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12906343 ↗
• MalfunctionSep 11, 2021Failure to Power Up; Failure to Power Up

  THE PATIENT WAS UNDERWATER FOR OVER 30 MINUTES BEFORE THE RESUSCITATION ATTEMPT. THE CREW DEPLOYED THE AUTOPULSE PLATFORM (SN (B)(4)) FOR RESUSCITATING THE PATIENT. THE CUSTOMER REPORTED THAT THE AUTOPULSE PLATFORM DID NOT POWER ON USING AUTOPULSE LI-ION BATTERIES (SN (B)(4), (B)(4), AND (B)(4)). PER THE CUSTOMER, THE PATIENT DIED, AND THE OUTCOME WAS NOT RELATED TO THE AUTOPULSE DEVICE. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. AFTER THE PATIENT EVENT, THE DISTRIBUTOR WAS UNABLE TO DUPLICATE THE CUSTOMER-REPORTED COMPLAINT. THE AUTOPULSE PLATFORM AND THE LI-ION BATTERIES USED DURING THE PATIENT EVENT WERE WORKED AS INTENDED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR #3010617000-2021-00874 FOR THE 1ST AUTOPULSE LI-ION BATTERY (SN (B)(4)). MFR #3010617000-2021-00875 FOR THE 2ND AUTOPULSE LI-ION BATTERY (SN (B)(4)). MFR #3010617000-2021-00876 FOR THE 3RD AUTOPULSE LI-ION BATTERY (SN (B)(4)).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457752 ↗
• MalfunctionAug 6, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTIVE MAINTENANCE ON (B)(6) 2021, THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED FUNCTIONAL TESTING DUE TO THE SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12286291 ↗
• MalfunctionMar 10, 2021Display or Visual Feedback Problem; Failure to Power Up; Noise, Audible; Display or Visual Feedback Problem; Failure to Power Up; Noise, Audible

  THE AUTOPULSE PLATFORM [SN (B)(4)] FAILED TO POWER UP. THE LCD DISPLAY IS NOT READABLE AND THE MOTOR MAKES A CLICKING SOUND. PATIENT USE INFORMATION WAS REQUESTED BUT NO ADDITIONAL INFORMATION WAS PROVIDED, THEREFORE PATIENT USE IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11449907 ↗
• MalfunctionFeb 6, 2021Use of Device Problem; Use of Device Problem

  DURING THE PATIENT USE, THE AUTOPULSE PLATFORM (SN (B)(4)) STOPPED PERFORMING COMPRESSIONS AND POWERED OFF BY ITSELF. THERE WERE NO USER ADVISORIES DISPLAYED ON THE PLATFORM. THE MANUAL CPR WAS PERFORMED DURING THE TROUBLESHOOTING. NO CONSEQUENCES OR IMPACT TO PATIENT. THE USER OBSERVED THE AUTOPULSE LI-ION BATTERY (SN (B)(4)) STATUS AS FLASHING GREEN LIGHTS BEFORE IT WAS PLACED INTO THE PLATFORM. THE PLATFORM WAS TESTED LATER ON WITH A GOOD KNOWN BATTERY AND FUNCTIONED APPROPRIATELY AND AS INTENDED. THE BATTERY (SN (B)(4)) WAS PLACED IN ANOTHER PLATFORM AND THE REPORTED ISSUE WAS DUPLICATED. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2021-00099 FOR AUTOPULSE LI-ION BATTERY SN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11290327 ↗
• MalfunctionFeb 2, 2021Failure to Power Up; Failure to Power Up

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED TO POWER UP. THE CUSTOMER TRIED TWO GOOD WORKING LI-ION AUTOPULSE BATTERIES WITHOUT ANY SUCCESS. NO DEVICE MALFUNCTION WAS REPORTED ON THE BATTERIES. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11269993 ↗
• MalfunctionJan 5, 2021Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING DEVICE CHECK, THE AUTOPULSE PLATFORM (SN (B)(4) ) DISPLAYED USER ADVISORY (UA) 41 (PATIENT TEMPERATURE SENSOR FAILURE) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11121302 ↗
• MalfunctionOct 20, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING BIOMED TESTING, THE AUTO-PULSE PLATFORM (SN 40657) DISPLAYED USER ADVISORY (UA) 12 (LIFE-BAND NOT PRESENT) ERROR MESSAGE. THE USER WAS UNABLE TO CLEAR THE UA 12 ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10709041 ↗
• MalfunctionOct 20, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING CUSTOMER'S FACILITY BIOMED TESTING, THE AUTOPULSE PLATFORM (SERIAL #(B)(4)DISPLAYED "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR ". NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10706714 ↗
• MalfunctionOct 19, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING DEVICE CHECK, THE DEMO AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED USER ADVISORY (UA) 07 (DISCREPANCY BETWEEN LOAD 1 AND LOAD 2 TOO LARGE) ERROR MESSAGE. AS REPORTED, THE UA07 ERROR WAS A REOCCURRING ISSUE WITH THE AUTOPULSE PLATFORM. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10702339 ↗
• MalfunctionJul 28, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING PREVENTIVE MAINTENANCE 03 JUL 2020, THE AUTOPULSE PLATFORM (SN (B)(4)) FAILED DURING FUNCTIONAL TESTING DUE TO FAULT 16 (TIMEOUT MOVING TO TAKE-UP POSITION) ERROR MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10336493 ↗
• MalfunctionApr 8, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN: (B)(4)) DISPLAYED A USER ADVISORY (UA)41 (PATIENT TEMPERATURE SENSOR FAILURE) ERROR MESSAGE. AS REPORTED, THE PLATFORM WAS MISTAKENLY STORED IN A LABORATORY FOR A FEW MONTHS PRIOR TO THE REPORTED ISSUE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9936644 ↗
• MalfunctionMar 27, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED A "SYSTEM ERROR, OUT OF SERVICE, REVERT TO MANUAL CPR" MESSAGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9888937 ↗
• MalfunctionMar 10, 2020Visual Prompts will not Clear; Visual Prompts will not Clear

  DURING A SHIFT CHECK, THE AUTOPULSE PLATFORM (SN (B)(4)) DISPLAYED THE USER ADVISORY (UA) 45 (NOT AT "HOME" POSITION AFTER POWER-ON/RESTART) ERROR MESSAGE. THE CUSTOMER WAS ABLE TO CLEAR THE ERROR, HOWEVER, THE PLATFORM DISPLAYED "ANALYZING PATIENT SIZE" AND A FAULT (UA) 08 (MOTOR CONTROLLER FAULT DETECTED) AFTER THE RESTART. THE CUSTOMER WAS UNABLE TO CLEAR THE ERRORS. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9814288 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K112998. One submission often covers many models, so check the product and lot details in each record.

• Z-0118-2023 · Sep 22, 2022 · Open, Classified
  AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model 100. used as an adjunct to manual CPR